Sleeping device market continues to be impacted by Philips CPAP recall

The company produces repair kits and replacement devices, but those efforts have resulted in a shortage of devices.

A year after a leading medical device manufacturer announced a recall of millions of positive airway pressure ventilators and devices, the issue continues to affect the sleeping device market and patients who depend on the devices.

Last June, Philips announced a voluntary recall of ventilators, continuous positive airway pressure (CPAP) machines and bi-level positive airway pressure (BiPAP) machines due to the degradation of sound dampening foam used in some of its models. The voluntary recall concerns machines manufactured between 2009 and April 2021. The company said patients using the devices could be exposed to foam particles or chemical emissions.

Eric Mongeau, national sales director at Aeroflow Healthcare, said 12 months later the situation is still difficult.

“From an impact perspective, not much has gotten horribly better,” he said.

Aeroflow is a North Carolina-based supplier of durable medical equipment that sells, among others, Philips devices.

Philips say it has produced 2.4 million repair kits and placement devices worldwide and shipped 1.1 million replacement devices in the United States, but Mongeau said the shift of manufacturing resources to the recall has created a supply shortage.

“The big challenge is that half the volume in the supply chain was gone with some of the recall, and then all those resources went into remediation – building new devices and then replacing the old ones – and none of those were can be sold on that market.”

Add to that the pandemic-related supply chain issues worldwide, and you have what Mongeau said amounts to “a double blow to the industry”.

Patients using Philips devices face a difficult decision. The American Academy of Sleep Medicine has: encouraged providers prescribe another aid if possible. However, if it’s not possible, the academy said doctors and patients should carefully weigh the risks of continuing to use the device against the risks of stopping therapy. When it announced the recall last June, Phillips said: it had received limited reports of headaches, upper respiratory tract irritation, coughing, chest pressure and sinus irritation, which it said could be associated with the foam. However, they said it’s also possible the problem could have other, more serious health consequences.

The recall and the rush to replace the devices has also led to a shortage of the semiconductors needed to build cloud-connected machines, prompting a rival manufacturer to re-market devices that use SD storage cards. , which record data that must then be downloaded by the patient or a healthcare provider to gain actionable insights.

Mongeau said the return to previous technology is bad news not only for medical device suppliers like Aeroflow, but also for patients, suppliers and insurers.

“Our entire business is based on early intervention, and you lose the ability to do that when you go to an SD card,” he said.

Mongeau said Aeroflow has been working to clear the order backlog by purchasing other FDA-approved equipment. He said at the moment there is about 4 weeks lead time between placing an order and fulfilling it, but he said his company hopes to halve that by the end of this month.

In the meantime, he and others hope the FDA will grant emergency use approvals (EUAs) to allow other devices to enter the U.S. market in an emergency, similar to how the agency are emergency powers used to increase the supply of ventilators after the emergence of the coronavirus disease 2019 (COVID-19).

“One of the things we’ve asked the FDA for is to actually have an EUA specific to the CPAP deficiency as this is also a public health emergency,” he said.

Mongeau said such a move is likely to lead to an influx of new entrants into the US market.

“There are really dozens of manufacturers worldwide that sell in Europe and Asia-Pacific [markets] that simply have not entered the US market because of the barriers to entry in the US,” he said. “And if there was an EUA specific to CPAP and sleep apnea, that could be another option.”

Mongeau said he is optimistic that such a move is in the offing. In the meantime, he said, demand for positive airway pressure machines continues to rise as more and more providers — including specialists such as cardiologists and endocrinologists — screen patients for sleep apnea.

“In the year this has been going on, our demand has nearly tripled,” he said. “And so it’s not slowing down.”

This article originally appeared on Managed Healthcare Executive.

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